Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure (SADHART-CHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00078286
Recruitment Status : Completed
First Posted : February 24, 2004
Results First Posted : February 27, 2013
Last Update Posted : February 27, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

February 20, 2004
February 24, 2004
May 11, 2009
February 27, 2013
February 27, 2013
November 2003
March 2008   (Final data collection date for primary outcome measure)
Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo [ Time Frame: Measured at Week 12 ]

Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.

The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period.

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Complete list of historical versions of study NCT00078286 on Archive Site
Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. [ Time Frame: Measured at Week 12 ]
Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.
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Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
Safety and Efficacy of Sertraline for Depression CHF
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.

Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and CHF; studies that examine the way CHF is affected by depression treatments are needed.

Participants in this study will be randomly assigned to receive either sertraline or placebo for 12 weeks. Assessments will be made at Weeks 2, 4, 6, 8, 10, and 12. Participants who do not respond to their treatment will have their medication dose adjusted following assessment. Interviews and rating scales will be used to assess depressive symptoms, cognitive status, psychiatric comorbidity, daily and chronic stress, and social support. A follow-up visit will take place 6 months, 1 year, 2 years, and 3 years after study completion.

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure, Congestive
  • Chronic Heart Failure
  • Depression
  • Drug: Sertraline
    Dosage ranging from 50 mg to 200 mg once a day
    Other Name: Zoloft
  • Drug: Placebo
    Dosage ranging from 50 mg to 200 mg once a day
    Other Name: Inactive pill
  • Experimental: Sertraline
    Participants will take sertraline for 12 weeks
    Intervention: Drug: Sertraline
  • Placebo Comparator: Placebo
    Participants will take placebo for 12 weeks
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic heart failure
  • Diagnostic and Statistical Manual- Fourth Edition (DSM-IV) criteria for major depression
  • Current use of any antipsychotic medication at study entry

Exclusion Criteria:

  • Life-threatening comorbidity with a 50% or higher likelihood of death within 1 year
  • History of psychoses, bipolar disorder, or severe personality disorder
  • History of alcohol or drug dependence in the last year
  • Severe physical disability that may interfere with the study
  • Neurological impairment
  • Active suicidal ideations
  • Current use of antidepressant medication(s) at the start of study medication
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH063211 ( U.S. NIH Grant/Contract )
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Duke University
Duke University
National Institute of Mental Health (NIMH)
Principal Investigator: Ranga Krishnan, PhD Duke University
Duke University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP